ATOMERRA atomoxetine (as hydrochloride) 10 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atomoxetine hydrochloride

Available from:

Arrow Pharma Pty Ltd

INN (International Name):

Atomoxetine hydrochloride

Authorization status:

Registered

Patient Information leaflet

ATOMERRA CAPSULES
_atomoxetine (as hydrochloride) _
_ _
ATOMERRA CMI v2.0
1
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ATOMERRA. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date shown on
the final page. More recent
information on this medicine may
be available. Make sure you speak
to your pharmacist or doctor to
obtain the most up to date
information on this medicine. The
updated leaflet may contain
important information about
ATOMERRA and its use that you
should be aware of.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ATOMERRA
against the benefits it may have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
WHAT ATOMERRA IS USED
FOR
ATOMERRA is used to treat
Attention Deficit Hyperactivity
Disorder (ADHD) in children 6 years
and older, adolescents and adults.
ADHD is a behavioural disorder that
causes lack of focus and/or
hyperactivity that is much more
frequent or severe than others who
are close in age or development.
ATOMERRA works by acting on brain
chemicals called amines which are
involved in controlling behaviour.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU. YOUR
DOCTOR MAY HAVE PRESCRIBED IT FOR
ANOTHER REASON.
Available evidence suggests that
ATOMERRA does not have a
significant potential for abuse.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
ATOMERRA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ATOMERRA IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
atomoxetine hydrochloride (the
active ingredient in ATOMERRA)
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ATOMERRA (ATOMOXETINE (AS HYDROCHLORIDE) CAPSULES
WARNINGS
SHORT-TERM PLACEBO CONTROLLED STUDIES EVALUATED OVER 2200 CHILDREN AND
ADOLESCENTS WITH
ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD). AMONG THE 1357
PATIENTS ON ATOMOXETINE, THERE
WAS A POSITIVE SIGNAL FOR SUICIDAL THOUGHTS (5 PATIENTS) AND
BEHAVIOURS (1 PATIENT) IN CHILDREN 12
YEARS OF AGE AND YOUNGER COMPARED TO PLACEBO (0/851). NO SUICIDES
OCCURRED IN THESE TRIALS.
ANYONE CONSIDERING THE USE OF ATOMOXETINE IN CHILDREN MUST BALANCE THE
RISK OF SUICIDALITY (SUICIDAL
THOUGHTS OR BEHAVIOURS) AGAINST THE CLINICAL NEED. PATIENTS WHO ARE
STARTED ON ATOMERRA SHOULD
BE CLOSELY MONITORED FOR SUICIDALITY (SEE SECTION .4 SPECIAL WARNINGS
AND PRECAUTIONS FOR
USE).
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NAME OF THE MEDICINE
atomoxetine (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5 mg, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg
or 100 mg of atomoxetine
(as hydrochloride)
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ATOMERRA is available as capsules for oral administration.
The capsule colours and markings are as follows:
5 MG
*
: Yellow capsule body and yellow cap with “5 mg” printed on the
capsule body in black
10 MG: White capsule body and white cap with “10 mg” printed on
the capsule body in black
18 MG: White capsule body and yellow cap with “18 mg” printed on
the capsule body in black
25 MG: White capsule body and blue cap with “25 mg” printed on the
capsule body in black
40 MG: Blue capsule body and blue cap with “40 mg” printed on the
capsule body in black
60 MG: Yellow capsule body and blue cap with “60 mg” printed on
the capsule body in black
80 MG: White capsule body and brown cap with “80 mg” printed on
the capsule body in black
100 MG: Brown capsule body and brown cap with “100 mg” printed on
the capsule body in black
*Not currently marketed
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ATOMERRA is indicated for the treatment of Atten